Moin Din is recruiting for an experienced Pharmacovigilance Director (Medic) to join a progressive Pharmaceutical company in the South East of the UK.
Responsibilities:
- Ensure quality of Serious Adverse Event data by providing medical expertise and judgment throughout the case-handling process with medical review of individual cases and analysis of safety reports.
- Accountable for the medical review and editing of individual case safety reports. This involves checking, editing where appropriate and reviewing the contents ensuring that the data reflects the original data from the investigator / reporter and ensuring that coding and assessment are correct and in line with regulatory and procedural documents (e.g. SOP) requirements.
- Accountable for the final medical review of case reports including decisions on SUSARs in a timely fashion and ensuring that all necessary queries have been generated, followed-up and addressed and that relevant data and reports are available.
- Prepare Line Listing concise summaries and be Primary Author for Development Safety Update Reports (DSURs) for assigned projects.
Education/experience:
- Medically qualified physician with significant post-registration clinical experience. MRCP or equivalent. GMC registered.
- Minimum experience level – At least 4 years Clinical Practice experience and at least 5 years in Industry (Pharma, CRO) and significant experience in drug safety.
- Detailed knowledge of Pharmacovigilance and safety reporting (especially EU, but also awareness of global pharmacovigilance regulatory requirements) and understanding of business impact of Pharmacovigilance function.
- Experience in the review, analysis and interpretation
of scientific data and presentation of results in a concise and clear manner to both scientific and non-scientific audiences.
- Knowledge and experience of implementation of signal detection processes.
How to apply:
For further detailed information and an informal discussion, please contact Moin Din in the first instance on 0207 470 5675 or email mdin@ckclinical.co.uk. Please quote reference CL24967 in all correspondence.
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